Keloid ScarsPhase 4NCT01720056
Verapamil vs Steroid to Prevent Keloid Recurrence
A Phase 4 study testing Verapamil and Kenalog 10 in people with Keloid Scars, run by The University of Western Australia at 1 site in Australia.
Trial summary
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keloid Scars
- What is being tested?
- Verapamil and Kenalog 10
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteAustralia
- Study dates
- Oct 2012to Mar 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient undergoing surgical removal of keloid
- Patient 18 years old or greater
- Length of excisional scar after surgical removal of keloid between 2 and 10 cm
Who cannot join
- Keloid in face or hands
- Pregnancy or lactation
- Dementia
- Any heart or pulmonary condition
- Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
- Systemic corticosteroidal therapy
Show all 9Show fewer
- Intralesional steroid treatment within 2 months of surgery to remove keloid
- Flap surgery
- Lesions to face, hands and other cosmetically sensitive areas
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.
Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.
- Conditions
- Keloid Scars
- Being tested
- Verapamil, Kenalog 10
- Medical subject headings
- Keloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerapamilDrug
Kenalog 10Drug
| Study group | Role | What they receive |
|---|---|---|
| Verapamil | Active comparator | Verapamil 2.5 mg/mL injection sc intralesionally Receives: Drug: Verapamil |
| Kenalog 10 | Active comparator | Kenalog 10 mg/mL injection sc intralesionally Receives: Drug: Kenalog 10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keloid recurrence
Measured: 1 year
Secondary outcomes (1)
Vancouver Scar Scale Score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Objective of study achieved after interim analysis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keloid ScarsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Western Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fiona M. Wood, The University of Western Australia
- Investigators
- Fiona M Wood, Professor, Principal investigator, The University of Western Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01720056
- Sponsor's protocol ID
- EC 067/2012
- Status last verified
- Jun 2015
- First submitted
- 30 Oct 2012
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Verapamil as an Adjunct for Prevention of Keloid Recurrence After Surgical Removal
- ClinicalTrials.gov ID
- NCT01720056
- Acronym / sponsor ID
- EC 067/2012
- Conditions
- Keloid Scars
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Objective of study achieved after interim analysis.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- The University of Western AustraliaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 1 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Keloid scarring is a severe cosmetic and painful disease of the skin. The gold standard treatment is yet to be clarified. This randomized clinical pilot study will compare the effects of two local treatments for preventing keloid recurrence after surgical removal; steroid and verapamil.
Study hypothesis: Intralesional therapy with the calcium antagonist verapamil has equal treatment efficacy as steroid injection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verapamil | Active comparator | Drug: VerapamilVerapamil 2.5 mg/mL injection sc intralesionally |
| Kenalog 10 | Active comparator | Drug: Kenalog 10Kenalog 10 mg/mL injection sc intralesionally |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient undergoing surgical removal of keloid
- Patient 18 years old or greater
- Length of excisional scar after surgical removal of keloid between 2 and 10 cm
Key exclusion criteria (9 listed)
- Keloid in face or hands
- Pregnancy or lactation
- Dementia
- Any heart or pulmonary condition
- Systemic treatment with beta-blockers, ACE-inhibitors or calcium antagonists
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verapamil | Drug | Verapamil |
| Kenalog 10 | Drug | Kenalog 10 |
Primary outcome
Keloid recurrence
Time frame: 1 year
1 secondary outcome
Vancouver Scar Scale Score
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Objective of study achieved after interim analysis.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona M Wood, Professor principal investigator
The University of Western Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Verapamil and Kenalog 10 in people with Keloid Scars, run by The University of Western Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Objective of study achieved after interim analysis.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keloid recurrence (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015; AzTrials last refreshed its copy on 31 Oct 2026.